A Multi-Center Randomized Controlled Trial of Adding ‎Brief Skill-Based Psychoeducation to Primary Needle and ‎Syringe Programs to prevent Human Immunodeficiency ‎Virus: Study Protocol‎

Objectives: Our objective was to ‎design an RCT in order to assess ‎the effects of adding a brief skill-‎based psychoeducation (PE) to ‎routine Needle and Syringe ‎Programs to reduce injection and ‎high risk sexual behaviors ‎associated with Human ‎Immunodeficiency Virus (HIV) ‎infection among referrals of ‎Drop-in Centers (DICs)‎‏.‏ Method/design: This was a ‎randomized control trial with the ‎primary hypothesis that adding ‎skill-based PE to the routine ‎needle syringe program (NSP) ‎provided in the DICs would be ‎more effective in reducing ‎injection and high risk sexual ‎behaviors associated with HIV ‎infection compared to the routine ‎programs. We intended to ‎randomly allocate ‎ 60 ‎patients per group after obtaining ‎informed written consent,. The ‎intervention group receive a ‎combination of brief ‎psychoeducation consisting two ‎individual sessions of skill-based ‎education concerning blood ‎borne viral infection, specifically ‎HIV. The control group received ‎the routine primary NSP services ‎provided in DIC. Study ‎assessments were undertaken by ‎a psychologist at baseline, 1 and ‎‎3 months after recruitment. The ‎primary outcome measure was ‎the comparison of the trend of ‎alterations in high risk sexual and ‎injection behaviors associated ‎with HIV infection during 3 ‎months after the initiation of the ‎intervention between the two ‎groups. Secondary outcome ‎measures included the ‎comparison of HIV/AIDS related ‎knowledge and client satisfaction ‎in the participants‏. ‏ Discussion: This paper presents ‎a protocol for an RCT of brief ‎skill-based PE by a trained ‎psychologist to reduce the sexual ‎and injection related high risk ‎behaviors among drug users who ‎received primary NSP services in ‎DIC. This trial tried to investigate ‎the efficacy of the intervention on ‎increasing HIV/AIDS related ‎knowledge and client ‎satisfaction. The results of ‎different indicators of high risk ‎behaviors will be discussed.‎